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Topic Significance & Study Purpose/Background/Rationale • With the increase in Immune Effector Cell (IEC) technology in both research and clinical settings, clinicians are challenged with the task of treating acute known adverse events, including cytokine release syndrome (CRS) and IEC-associated neurotoxicity syndrome (ICANS), along with the determining and managing long-term complications of IEC therapies, many of which are unknown. Methods, Intervention, & Analysis • Initiate a standardized protocol for early intervention of treatment for CRS and ICANS with recommendations by the ASTCT (American Society of Transplant and Cellular Therapy). • Create an institutional framework for an IEC therapy long-term follow up clinic for. • Collect data on long-term adverse events post-IEC therapy and subsequently develop a standardized approach to appropriately diagnose and treat this patient population. Findings & Interpretation • The logistics of treating a patient with IEC therapy through clinical trials has helped standardize the process with commercial therapies. • Through IEC clinical research, acute care of adverse events has informed clinical care with commercial products and these lessons will inform long-term follow up care of this patient population. • The need for a dedicated long-term IEC follow up clinic, with specialized clinicians, has been identified to appropriately follow and treat side effects as needed. • The ever-increasing amount of data on patients that have received IEC therapies will continue to shape how these patients are followed in the future. • Focus on the long-term needs of IEC therapy patients will include: immunizations, hypogammaglobulinemia, HIV/other viral reactivation, increased infections, etc. Discussion & Implications • The vision of creating a long-term follow up clinic with dedicated clinicians to help create a standardized approach to surveillance of IEC patients post-therapy is undergoing feasibility assessment. • The integrated approach to implementing clinical trials processes within the commercial IEC environment has helped shape the way we treat and follow up with this patient population. With the lack of long-term data on late breaking side effects that may arise, these IEC patients should be followed by a specialized team/clinic to increase positive patient outcomes. |
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